Premature Birth Clinical Trial
Official title:
Trial to Evaluate a Specified Type of Apgar (TEST-APGAR) Follow-Up Study
A specified version of the Apgar-Score, that can be used in newborns under resuscitation, was developed and its value to predict chronic damage in preterm infants will be tested.
Specifications of the individual items of the original Apgar score were suggested. These
specifications slightly changed the Apgars' perspective, but did not alter the number of its
components. The specified Apgar should therefore be easily applicable to every delivery room
around the world. As a result of these specifications, the Apgar score will not express the
efforts of the infant but describe its condition, independently of the requirements needed
to achieve this condition. The advantage of the proposed definitions is the applicability in
all infants, regardless of resuscitative efforts or gestational age.
To validate the accuracy of the specified version to predict neonatal mortality and long
term neurological outcome in preterm infants the present prospective, observational study is
planned. The study will test the hypothesis that the specified APGAR-score predicts
mortality and morbidity better at 2 years of age than the conventional Apgar-score.
Furthermore, the predictive reliability of the specified Apgar can be improved in
combination with perinatal data respectively with the expanded Apgar version of the
AAP/ACOG.
The primary outcome "condition at 2 years of age" is composed of death and a major
neurological deficit. In this case "neurological deficit" is defined by the presence of one
of the followings characteristics: index of mental development (Bayley Scale II) <85,
blindness, deafness, cerebral palsy.
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Observational Model: Cohort, Time Perspective: Prospective
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